Clovis Oncology files for rociletinib approval in USA and Europe

Shares of Clovis Oncology (Nasdaq: CLVS) gained nearly 2% to $86.21 in early trading today, when the company announced regulatory filings in the USA and Europe for its lung cancer drug candidate rociletinib.

US personalized cancer therapy specialist Clovis submitted its New Drug Application regulatory filing to the Food and Drug Administration for rociletinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test.

Rociletinib is the company’s novel, oral targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of NSCLC in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M. Rociletinib was granted Breakthrough Therapy designation by the FDA in May 2014.